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BOVINE CARTILAGE AND MARROW EXTRACT
1275
BOVINE CARTILAGE AND MARROW EXTRACT
SIR,-Appraising the benefits of ’Rumalon’ Dr Schacht and Dr Roetz (April 29, p 963) seem to negate possible risks of this extract of bovine cartilage and bone marrow. Severe anaphylactoid reactions to ’Arumalon’ have been reported to the Drug Commission of the German Medical Profession. In April and May, 1989, we were confronted with further cases of severe hepatotoxicity, an anaphylactoid reaction with paraesthesia, and an inflammatory injection site reaction. The major feature that discriminates a drug reaction is its association with exposure to a specific drug and the rapid resolution of symptoms when the drug is discontinued. This is also seen well in the lymphocyte transformation test (LTT), which usually becomes negative after withdrawal of the drug (as in both runalon casesl3) and positive again on re-exposure.1-6 The LTT is therefore helpful in evaluating the allergic nature of drug-induced side effects-but it is not an indicator of disease activity. In our experience, however, a positive LTT may correlate well with symptoms associated with drug intake .17 Schacht and Roetz point out that in our case-report’ the patient was also on bezafibrate. However, bezafibrate was started 5 days after the manifestation of the nephrotic syndrome.l3 The adverse effects of rumalon, its poor standardisation, and its insufficient clinical efficacy prompted the German regulatory authority not to recommend a licence for for this this agent aeent. L. P. A. BERG Medical Clinic, H. DÜRK University of Tubingen, West Germany J. SAAL recommend a licence
Drug Commission of the German Medical Profession,
Cologne
G. HOPF
1. Durk H, Haase K, Saal J, Becker W, Berg PA. Nephrotic syndrome after injections of bovine cartilage and marrow extract. Lancet 1989; i: 614. 2. Glogner P, Berg PA, Becker EW. Nebenwirkungen eines Knorpelextrakts Dtsch Med Wochenschr 1989; 8: 319. 3. Berg PA. Nebenwirkungen eines Knorpelextrakts. Dtsch Med Wochenschr 1989; 20: 809-10. 4 Brattig NW, Diao GJ, Berg PA. (+) Cyanidanol-3 induced fever and its pathogenesis. In: Conn O, ed. International workshop on ( +)-cyanidanol-3 in disease of the liver Proc R Soc Med 1981; 47: 227-33. 5. Schuff-Werner P, Berg PA. Immunreaktionen bei Pseudo-Lupus-Syndrom. Klin Wschr 1980; 58: 935-41. 6. Brattig NW, Diao GJ, Berg PA. The specificity of the lymphocyte transformation test in a patient with hypersensitivity reactions to pyrazolone compounds: 10-week follow-up study before and after rechallenge Eur J Clin Pharmacol 1988; 35: 39-45. 7 Berg PA, Schuff-Werner P, Henning H. Immune reactions to drugs and metabolites in man. In. Eddleston ALWF, Weber JCP, Williams R, eds. Immune reactions in liver disease. Tunbridge Wells: Pitman, 1979: 247-58.
THIRD WORLD AND EUROPEAN COMMUNITY
SIR,-We support the call by Dr Chan and others (April 15, p 849) on governments and financial institutions in the developed world to lift the debt burden on Third World countries. This is crucial to improving the health of the world’s poor. Another intolerable burden of many of the poorest countries are adverse terms and conditions of international trade. With almost one-fifth of the world’s trade the European Community has significant effects on the health of many of the world’s poor. Sugar is a well-known example; the dumping of huge European sugar surpluses on the world market has contributed to the fall in world prices, threatening the livelihood of 12 million sugar workers and their families world wide.! In the run-up to the European elections we urge everyone with an interest in improving the health of the world’s poor to lobby candidates for election to the European Parliament. The following
issues are especially important: (1) Reform of the Common Agricultural Policy, with particular attention to farmers in the Third World. (2) Proper consideration of the effects on Third World countries of 1992’s single European market. There are real fears of a "fortress Europe", worsening the opportunities for the Third World to trade with Europe. (3) Urging the EEC to take a progressive role in General Agreement on Tariffs and Trade talks, giving much greater emphasis to favourable terms for the poorest countries.
The European Community directly and indirectly affects the health and living conditions of millions of the world’s poor. We should challenge our would-be parliamentary representatives in Europe to take this responsibility seriously. Department of Community Medicine, Stopford Building, University of Manchester, Manchester M1 3 9PL 1. Coote B The
N. UNWIN S. GARNETT C. HARRISON K. SNEE L. DAVIES R. GORTON S. SMART
hunger crop Poverty and the sugar industry.
London: Oxfam Public
Affairs Unit, 1988
Medicine and the Law Sterilisation of a Mentally Incapable Woman ON May 5, 1989, the House of Lords declared that
an
operation sterilise F, a 36-year-old mentally incapable woman, was lawful and in her best interests.’ This decision (the reasons were published on May 24) has wide-ranging implications. The case pivoted on whether or not the sterilisation of a mentally incapable woman was lawful with (or without) the leave of the High Court, but the arguments also concerned the uncertain status of all treatments needed by mentally incapable adults. Does a patient’s incapacity to give valid consent render treatment automatically unlawful; does the court have a power to consent on behalf of incapable adults; and should the court consent to all or any medical treatments, trivial or routine or serious and irreversible. Giving the leading judgment, Lord Brandon said that the common law allowed a doctor to treat adults who were incapable of consenting provided the procedure (operation or other treatment) was in the best interests of the patient. The law would regard a treatment as being in the patient’s best interests only if it was done to save life or to ensure improvement or prevent deterioration in physical or mental health. When people lacked the capacity to take medical treatment decisions, others had to take them on their behalf or they would be deprived of care they needed and to which they were entitled. In many such cases, it would not only be lawful for doctors to give treatment, but also their common law duty. A mentally disabled adult who cannot consent to treatment will, accidents and emergencies apart, usually either be in the care of guardians and referred to doctors for treatment or reside (or be detained in) a mental hospital. It would be up to the doctors to use their "best endeavours" to do what was in the best interests of the patient. The lawfulness of such treatment would depend not on any approval or sanction of the court but on whether the operation or other treatment was in the patient’s best interest. The standard that would be applied (by a court) would be that of the reasonably competent doctor practising in the specialty (as laid down in the Bolam case2 in deciding medical negligence claims). to
The House of Lords has implicitly made it clear that the courts have no wish to encroach on to the territory of the day-to-day medical decision-making. Doctors have thus been given a wide mandate to set their own standards of practice, and the court has sensibly rejected a trip down the interventionist path adopted by some other jurisdictions. English law, as expressed in F, endorses the doctor’s traditional clinical discretion: Lord Brandon said that it was as well the law was so because if every operation or other treatment required the approval of the court medical care would grind to a halt. Sterilisation of mentally handicapped woman approved by House of Lords. Lancet 1989, i: 1089. 2. Bolam v Fnem Hospital Management Committee 1957 1 WLR 582 1. Brahams D
BOVINE CARTILAGE AND MARROW EXTRACT
SIR,-Appraising the benefits of ’Rumalon’ Dr Schacht and Dr Roetz (April 29, p 963) seem to negate possible risks of this extract of bovine cartilage and bone marrow. Severe anaphylactoid reactions to ’Arumalon’ have been reported to the Drug Commission of the German Medical Profession. In April and May, 1989, we were confronted with further cases of severe hepatotoxicity, an anaphylactoid reaction with paraesthesia, and an inflammatory injection site reaction. The major feature that discriminates a drug reaction is its association with exposure to a specific drug and the rapid resolution of symptoms when the drug is discontinued. This is also seen well in the lymphocyte transformation test (LTT), which usually becomes negative after withdrawal of the drug (as in both runalon casesl3) and positive again on re-exposure.1-6 The LTT is therefore helpful in evaluating the allergic nature of drug-induced side effects-but it is not an indicator of disease activity. In our experience, however, a positive LTT may correlate well with symptoms associated with drug intake .17 Schacht and Roetz point out that in our case-report’ the patient was also on bezafibrate. However, bezafibrate was started 5 days after the manifestation of the nephrotic syndrome.l3 The adverse effects of rumalon, its poor standardisation, and its insufficient clinical efficacy prompted the German regulatory authority not to recommend a licence for for this this agent aeent. L. P. A. BERG Medical Clinic, H. DÜRK University of Tubingen, West Germany J. SAAL recommend a licence
Drug Commission of the German Medical Profession,
Cologne
G. HOPF
1. Durk H, Haase K, Saal J, Becker W, Berg PA. Nephrotic syndrome after injections of bovine cartilage and marrow extract. Lancet 1989; i: 614. 2. Glogner P, Berg PA, Becker EW. Nebenwirkungen eines Knorpelextrakts Dtsch Med Wochenschr 1989; 8: 319. 3. Berg PA. Nebenwirkungen eines Knorpelextrakts. Dtsch Med Wochenschr 1989; 20: 809-10. 4 Brattig NW, Diao GJ, Berg PA. (+) Cyanidanol-3 induced fever and its pathogenesis. In: Conn O, ed. International workshop on ( +)-cyanidanol-3 in disease of the liver Proc R Soc Med 1981; 47: 227-33. 5. Schuff-Werner P, Berg PA. Immunreaktionen bei Pseudo-Lupus-Syndrom. Klin Wschr 1980; 58: 935-41. 6. Brattig NW, Diao GJ, Berg PA. The specificity of the lymphocyte transformation test in a patient with hypersensitivity reactions to pyrazolone compounds: 10-week follow-up study before and after rechallenge Eur J Clin Pharmacol 1988; 35: 39-45. 7 Berg PA, Schuff-Werner P, Henning H. Immune reactions to drugs and metabolites in man. In. Eddleston ALWF, Weber JCP, Williams R, eds. Immune reactions in liver disease. Tunbridge Wells: Pitman, 1979: 247-58.
THIRD WORLD AND EUROPEAN COMMUNITY
SIR,-We support the call by Dr Chan and others (April 15, p 849) on governments and financial institutions in the developed world to lift the debt burden on Third World countries. This is crucial to improving the health of the world’s poor. Another intolerable burden of many of the poorest countries are adverse terms and conditions of international trade. With almost one-fifth of the world’s trade the European Community has significant effects on the health of many of the world’s poor. Sugar is a well-known example; the dumping of huge European sugar surpluses on the world market has contributed to the fall in world prices, threatening the livelihood of 12 million sugar workers and their families world wide.! In the run-up to the European elections we urge everyone with an interest in improving the health of the world’s poor to lobby candidates for election to the European Parliament. The following
issues are especially important: (1) Reform of the Common Agricultural Policy, with particular attention to farmers in the Third World. (2) Proper consideration of the effects on Third World countries of 1992’s single European market. There are real fears of a "fortress Europe", worsening the opportunities for the Third World to trade with Europe. (3) Urging the EEC to take a progressive role in General Agreement on Tariffs and Trade talks, giving much greater emphasis to favourable terms for the poorest countries.
The European Community directly and indirectly affects the health and living conditions of millions of the world’s poor. We should challenge our would-be parliamentary representatives in Europe to take this responsibility seriously. Department of Community Medicine, Stopford Building, University of Manchester, Manchester M1 3 9PL 1. Coote B The
N. UNWIN S. GARNETT C. HARRISON K. SNEE L. DAVIES R. GORTON S. SMART
hunger crop Poverty and the sugar industry.
London: Oxfam Public
Affairs Unit, 1988
Medicine and the Law Sterilisation of a Mentally Incapable Woman ON May 5, 1989, the House of Lords declared that
an
operation sterilise F, a 36-year-old mentally incapable woman, was lawful and in her best interests.’ This decision (the reasons were published on May 24) has wide-ranging implications. The case pivoted on whether or not the sterilisation of a mentally incapable woman was lawful with (or without) the leave of the High Court, but the arguments also concerned the uncertain status of all treatments needed by mentally incapable adults. Does a patient’s incapacity to give valid consent render treatment automatically unlawful; does the court have a power to consent on behalf of incapable adults; and should the court consent to all or any medical treatments, trivial or routine or serious and irreversible. Giving the leading judgment, Lord Brandon said that the common law allowed a doctor to treat adults who were incapable of consenting provided the procedure (operation or other treatment) was in the best interests of the patient. The law would regard a treatment as being in the patient’s best interests only if it was done to save life or to ensure improvement or prevent deterioration in physical or mental health. When people lacked the capacity to take medical treatment decisions, others had to take them on their behalf or they would be deprived of care they needed and to which they were entitled. In many such cases, it would not only be lawful for doctors to give treatment, but also their common law duty. A mentally disabled adult who cannot consent to treatment will, accidents and emergencies apart, usually either be in the care of guardians and referred to doctors for treatment or reside (or be detained in) a mental hospital. It would be up to the doctors to use their "best endeavours" to do what was in the best interests of the patient. The lawfulness of such treatment would depend not on any approval or sanction of the court but on whether the operation or other treatment was in the patient’s best interest. The standard that would be applied (by a court) would be that of the reasonably competent doctor practising in the specialty (as laid down in the Bolam case2 in deciding medical negligence claims). to
The House of Lords has implicitly made it clear that the courts have no wish to encroach on to the territory of the day-to-day medical decision-making. Doctors have thus been given a wide mandate to set their own standards of practice, and the court has sensibly rejected a trip down the interventionist path adopted by some other jurisdictions. English law, as expressed in F, endorses the doctor’s traditional clinical discretion: Lord Brandon said that it was as well the law was so because if every operation or other treatment required the approval of the court medical care would grind to a halt. Sterilisation of mentally handicapped woman approved by House of Lords. Lancet 1989, i: 1089. 2. Bolam v Fnem Hospital Management Committee 1957 1 WLR 582 1. Brahams D